Autonomic Dysreflexia in Spinal Cord Injury

Not Applicable

Completed

• Conditions: Autonomic Dysfunction; Spinal Cord Injured
• Interventions: Procedure: bowel emptying

• Registration Number: NCT01059370
• Lead Sponsor: University of Aarhus

Brief Summary

Autonomic dysreflexia in high spinal cord-injured can be initiated by a full bladder or bowel, or when trying to empty either. This randomised study aims at evaluating whether irrigation procedure or digital stimulation or evacuation of the rectum is less provocative of autonomic dysreflexia. Participants have their bowels emptied on different days, in the morning fasting. Bladder filling with sterile saline water is evaluated on a third day as a control.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-01-28
• Study First Posted: 2010-01-29
• Primary Completion: 2011-11
• Study Completion: 2012-03
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-15
• Last Update Posted: 2012-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. People with a spinal cord injury above th6 and with symptoms of autonomic dysreflexia.
2. At least one year post injury.
3. 18 years or older.
4. Informed consent.

Exclusion Criteria

1. Usage of prophylactic anti-autonomic dysreflexia medication.
2. Pregnant or breastfeeding.
3. People who is not able to follow the sudy protocol.
4. No former major surgery in the abdomen or pelvic region.
5. No former radiotherapy in the pelvic region.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autonomic dysrefleksia	bowel emptying	Autonomic dysreflexia in SCI when emptying bowels or filling bladder

Primary Outcome Measures

Name	Time	Method
Intervention induces 25 % raise in BP compared to baseline measurements.	Outcome are monitored all through bowel or bladder-procedure at each of three study-days, and compaire to measurements at baseline.

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark